FDA Announces September 8, 2008 Public Meeting on Nanoscales in Foods, Drugs, Cosmetics, Etc.
The Food and Drug Administration is holding a public meeting on September 8, 2008 and is requesting public comments by October 24, 2008 on the implementation of recommendations made by the Nanotechnology Task Force Report (the Report) relating to the development of FDA guidances.
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The Report's recommendations covered foods (including dietary supplements), food and color additives (including food contact substances), animal drugs and feeds, cosmetics, human drugs and biologics, and medical devices.
In addition to requesting comments in response to the questions in this notice and those that will be discussed at the public meeting, FDA is announcing a request for available data and information on the effects of nanoscale1 materials on quality, safety, and, where relevant, effectiveness of products subject to FDA oversight.
In July 2007, FDA issued the Report which (1) analyzes scientific and regulatory considerations relating to the safety and effectiveness of FDA-regulated products containing nanoscale materials regulated by FDA, and making recommendations regarding these considerations; (2) summarizes the state of the science for biological interactions with nanoscale materials; (3) recommends that the FDA coordinate with other Federal agencies and the private sector in research and other activities to increase general scientific understanding and facilitate assessment of data needs for regulated products.
The FDA states that it has been considering development of guidances recommended in the Report and believes that holding a public meeting and announcing this request for comments and available data will provide information that will assist in this task.
In addition, FDA is working with the National Institutes of Health (particularly the NanoHealth Enterprise) to explore methods for receiving and sharing data relating to, for example, general product development, including research on failed product candidates, and biological interactions of certain characteristics of nanoscale materials.
The primary purpose of the meeting is to determine what factors the agency should consider in providing guidance on: (1) the information and data that may be needed to demonstrate the safety and effectiveness of FDA-regulated products containing nanoscale materials, and (2) the circumstances under which a product's regulatory status might change due to the presence or use of nanoscale materials (for example, making a device no longer exempt from 510(k) submission requirements).
1Nanotechnology allows scientists to work on the scale of molecules to create, explore, and manipulate materials measured in nanometers; billionths of a meter.
- FDA's public meeting scheduled for 09/08/08 in Rockville, MD
-registration for persons who wish to make an oral presentation are due by 09/02/08
- comments due by 10/24/08
FDA contact - Megan Clark (301) 827-3360
FDA notice (D/N FDA-2008-N-0416, FR Pub 08/07/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-18132.pdf.
FDA Web site on September 8, 2008 meeting, including detailed agenda, product-specific questions to be discussed, etc. available at http://www.fda.gov/nanotechnology2008/.